Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Summary

We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)

Conditions

• Crohn's Disease

Interventions

DRUG

Adalimumab

single intralesional administration during endoscopy process

DRUG

placebo

single intralesional administration during endoscopy

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  collaborator OTHER

• Sara Varea

  lead OTHER

Principal Investigators

• Begoña González Suarez, MD · Hospital Clinic of Barcelona

• Lucía Márquez, MD · Hospital del Mar

• Alfredo Mata, MD · Hospital de Sant Joan Despí Moisès Broggi

• Carlos Huertas, MD · Hospital Josep Trueta

• Lidia Argüello, MD · Hospital La Fe

• Cecilia González, MD · Gregorio Marañón Hospital

• Ana Echarri, MD · Complexo Hospitalario Arquitecto Marcide-Novoa Santos

• Carme Loras · Hospital Mútua Terrassa

• Maria D Martín Arranz · Hospital Universitario La Paz

• Manuel Barreiro · Complexo Hospitalario de Santiago

• Yago González · Hospital Universitario Puerta del Hierro

• Beatriz Sicília · Complejo asistencial Universitario de Burgos

• Sam Korrhami · Hospital Son Espases

• Ana Gutiérrez · Hospital General Universitario de Alicante

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-14

Primary Completion

2018-06-30

Completion

2018-06-30

Countries

• Spain

Study Locations